HESI Insights - November 2024

HESI is proud to announce the 2024 THRIVE Grant awardees! This year’s recipients—Meghan Sise, Gavin Richardson, En Cheng, and Arabella Young—are leading innovative research to minimize the side effects of cancer treatment, improving the quality of life for patients around the globe. Their groundbreaking work embodies a dedication to empowering patients, enabling them not only to overcome cancer but to thrive in a vibrant, fulfilling life. Join us in celebrating these remarkable scientists as they shape a brighter, more hopeful future for cancer care.

The HESI THRIVE 2025 Seed Grant Program will open its call for Letters of Intent on Monday, November 25, 2024. This grant supports innovative research aimed at predicting, preventing, and reducing adverse effects from cancer therapy. To learn more about this unique funding opportunity, visit the webpage at https://hesithrive.org/.

We are thrilled to announce that Elena Kozlova, a PhD candidate at the University of California, Riverside, USA, and Parisa Varshosaz, a PhD candidate at Laurentian University, Ontario, Canada, have been awarded the 2024 HESI DART Professional Development Award. This award provides each recipient with $2,000 USD to support attendance at professional meetings or trainings within the next year.

Elena’s research focuses on the impact of early-life exposure to polybrominated diphenyl ethers (PBDEs) on social brain development, while Parisa is investigating the role and regulation of retinoic acid (RA) signaling during cranial development.

These awards support the DART program’s mission to increase awareness of DART career paths, build collaborative networks, and highlight rising talent in the field. Congratulations to Elena and Parisa on this well-deserved recognition of their important work!

Please join HESI in welcoming our newest Scientific Program Manager, Dr. Alexandra Taraboletti. Alex brings a strong background in academic research and government programming. She completed her postdoctoral training in the Tumor Biology program at Georgetown University and earned her PhD in Chemistry, specializing in bioanalytical chemistry. Her expertise spans a wide broad range of areas, with a focus on advancing innovative solutions in health and environmental safety.

Alex also has a passion for visual science communication, leveraging her skills as a graphical editor and illustrator. She will be joining the HESI Genetic Toxicology and Cardiac Safety committees.

Welcome Alex!

We are excited to share that HESI Scientific Program Manager, Claire O’Brien, and her partner, Nick, have welcomed baby Teddy to the HESI family! Teddy was born on July 20th weighing 6 pounds and 7 ounces. He is already an adventurer and nature enthusiast – spending as much time as possible staring at trees, pictures of fish, and going on long walks. Teddy can’t wait to lead the team on nature walks, tree-watching breaks, and fishing trips and to join one of HESI’s Eco projects!

We are also thrilled to welcome Claire back to work and look forward to hearing all about her family’s adventures with Teddy!

The HESI Botanical Safety Consortium’s Hepatotoxicity Working Group has developed a screening strategy to identify hepatotoxicity and drug interaction risks associated with botanicals. Botanical products are complex mixtures that are difficult to test in traditional toxicology mammalian models due to their inherent variability. The liver, being a central site for metabolism, is particularly vulnerable to potential toxicity and interactions with other drugs.

Key takeaways from this publication include:

• New Approach Methodologies (NAMs): Exploration of NAMs that are being proposed (in vitro and in silico models) to screen hepatotoxicity and botanical-drug interactions effectively.
• Broad Botanical Testing: Testing a variety of botanicals through case studies, with assays evaluating cellular and molecular markers related to liver health.
• Development of a Safety Toolkit: Creation of a toolkit to assist researchers in screening botanicals, informing further studies, and potentially reducing animal testing.

This publication is valuable for toxicologists, regulatory bodies, and botanical product researchers interested in advancing safety assessment frameworks for botanical supplements.

The full article is open access and can be read at the link below.

Developing a Screening Strategy to Identify Hepatotoxicity and Drug Interaction Potential of Botanicals. Roe et al., 2024. Journal of Dietary Supplements. https://doi.org/10.1080/19390211.2024.2417679

This comprehensive review, from HESI’s Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee, explores the use of transcriptomic points of departure (tPODs) to enhance toxicological safety assessment. The article delves into current methodologies for deriving tPODs from transcriptomic data, identifying sources of variability, key gaps in knowledge, and areas for future research. It highlights the potential of tPODs to deliver faster and health-protective toxicological assessments compared to traditional methods.

Key Takeaways:

• Efficiency and Innovation: tPODs offer a novel approach to derive reference doses using short-term studies, reducing reliance on long-term animal testing.
• Bioinformatic Workflows: The review provides a detailed nine-step framework for tPOD derivation, including data processing, normalization, and response detection.
• Research Priorities: Critical areas for improvement include study design optimization, platform standardization, and enhanced methods for uncertainty quantification.
• Regulatory Relevance: The findings emphasize the integration of tPODs into regulatory toxicology, supported by robust bioinformatic tools like EPA’s ETAP and BMDExpress.

This article is a must-read for:

• Toxicologists and Risk Assessors seeking advanced methodologies for safety assessments.
• Bioinformaticians interested in data workflows and transcriptomics.
• Academics and Industry Professionals involved in molecular toxicology research.

The full article is open access and can be read at the link below.

Bioinformatic Workflows for Deriving Transcriptomic Points of Departure: Current status, Data Gaps, and Research Priorities. O’Brien et al., Toxicological Sciences. https://doi.org/10.1093/toxsci/kfae145

On October 15–16, 2024, HESI and FDA-CDER co-hosted a dynamic workshop titled Nitrosamines Ames Data Review and Method Development. The event was held at the FDA’s White Oak campus and was also available virtually. This unique gathering brought together over 75 experts from regulatory agencies, industry, and academia worldwide to review and discuss Ames data results from HESI’s Genetic Toxicology Technical Committee, FDA’s CDER and NCTR, and the European Medicines Agency’s MutaMind project.

The workshop explored critical aspects of mutagenicity testing for nitrosamines, including study design, the enhanced Ames assay, and the correlation between Ames test results and in vivo mutagenicity outcomes. While consensus was not reached on all issues, the open exchange of perspectives led to pivotal recommendations and identified key future directions.

Thank you to all participants for contributing to such a valuable session! Learn more about the HESI Nitrosamines Research Program here.

HESI’s Immuno-Safety Technical Committee (ITC) received significant recognition at the recent CHI Immunogenicity & Bioassay Summit in Washington, DC. The committee’s work was lauded as a “North Star,” inspiring innovations in immunogenicity assessment through advanced T-cell platform technologies. At the summit, Laurent Malherbe delivered an insightful update on the HESI/AAPS collaborative pilot study, which focuses on developing and characterizing standard control proteins for in vitro immunogenicity assessments.

This collaborative project highlights HESI’s commitment to bringing together experts in the field to address critical questions, drive advancements in risk assessment, and push the boundaries of scientific innovation. We’re proud to contribute to such impactful work!

Our recent ITC Leadership Strategy Retreat on October 18 demonstrated that a little planning goes a long way—and can even be exciting! With a clear roadmap in place, the Immuno-Safety Technical Committee set dynamic goals for the next 12 months, defined leadership roles, and, yes, even shared a few laughs along the way. Each working group lead emerged with tailored action plans and a renewed commitment to ITC’s mission.

Thanks to everyone’s collaboration, we’re ready to tackle big priorities with a fresh focus and actionable milestones. Here’s to making strategy sessions not only productive but also enjoyable!

Over 60 Developmental and Reproductive Toxicology (DART) subject matter experts met online for two half-days for their Fall Business Meeting. In addition to reviewing progress across various workstreams, the committee approved a new working group focused on Germline Transmission and New Modalities. This new working group (WG) will address best practices for risk assessment of DART and germline transmission and will plan a workshop for Spring 2026.

The meeting also included discussions on hot topics facing the community. Contact Connie or Shermaine with any questions about DART WGs!

HESI had a strong presence at the SETAC North America Annual Meeting held in Fort Worth, Texas, from October 20-24, 2024. HESI staff and members contributed significantly across multiple sessions, presentations, and discussions. Highlights included two co-chaired sessions, two posters, two oral presentations, and participation in a panel discussion. Full details can be found on the event page here.

The HESI team’s involvement underscored important themes, including New Approach Methodologies (NAMs), ecological risk assessment, and UVCB characterization, highlighting HESI’s dedication to advancing environmental safety and regulatory science.

At the 7th Annual TPD Summit in Boston, MA, TPDS Committee members actively contributed to key discussions on safety considerations for targeted protein degraders. On October 29th, they participated in a panel discussion addressing critical safety aspects, and on October 30th, HESI Senior Program Advisor Raegan O’Lone delivered a talk titled “Collaborative Approaches to Advancing Integrated Safety Assessment of Targeted Protein Degraders.”

On October 21–22, 2024, the HESI PATB committee and the “REQUIMTE Lab” at the University of Porto co-hosted a workshop titled “Safety Assessment of Newly Expressed Proteins in Foods: Need for Evolution?” in Porto, Portugal.

This workshop convened over 30 global experts on-site and 150 online attendees to discuss advances in protein safety assessment for genetically modified (GM) foods and other novel foods derived from biotechnology.

The program featured a regulatory session with key opinion leaders from CTNBio (Brazil), EFSA, Nanyang Technological University (Singapore), the National Biosafety Authority (Kenya), and the US FDA. Additionally, it included technical sessions addressing specific challenges and case studies related to intractable proteins and complex mixtures of proteins. A session also explored new in silico and in vitro approaches to assess readiness for New Alternative Methods (NAMs) in the GM/Novel Foods Safety Space.

A key takeaway from the final working session, which integrated learnings from the workshop, was that as case-by-case approaches and weight-of-evidence play an increasing role in the safety assessment of these products, there is a growing need for clear criteria to support decision-making for novel product safety.

We extend our gratitude to all contributors and look forward to future collaborative efforts in this space.

For additional information, visit the event page: https://hesiglobal.org/event/hesi-workshop-safety-assessment-of-newly-expressed-proteins-in-foods-need-for-evolution/ or contact Lucilia Mouries (lmouries@hesiglobal.org) and Claire O’Brien (cobrien@hesiglobal.org).

HESI Senior Scientific Program Manager, Connie Mitchell, highlighted the Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee in a talk titled “Collaborative Vision for Omics-Based Chemical Testing” in a session at the EPA NAMs Conference exploring the use of omics for decision making.

On November 8, 2024, HESI Executive Director, Syril Pettit, delivered the Dr. Jacob Adams Memorial Lecture at the 2nd International Pediatric Cardio-Oncology Conference in Cincinnati, OH. Her talk, titled “Making Patient Quality of Life an Active Research Priority,” emphasized HESI’s commitment to advancing cancer patient quality of life as a vital focus within translational research. This event provided an inspiring platform for interaction with survivors, clinicians, and researchers. Special thanks were extended to Dr. Steven Lipshultz for his enduring dedication and leadership in this essential field.

Visit the HESI THRIVE webpage for more information about how HESI works to make patient Quality of Life an active research priority.

On November 8th, the HESI Environmental Epidemiology for Risk Assessment Committee hosted an engaging three-part internal workshop on Quantitative Bias Analysis (QBA). The workshop aimed to deepen participants’ understanding of QBA calculations, a critical tool for addressing potential biases in epidemiological studies. This foundational effort sets the stage for the committee to develop training materials that will make QBA techniques more accessible to epidemiologists and risk assessors. Stay tuned for updates as this initiative progresses toward equipping professionals with enhanced tools for more accurate and transparent risk assessments.

For more information contact Sandrine Deglin

Is your organization facing new scientific challenges? Are you seeking a collaborative forum to help generate data, develop methodologies, build consensus on applications for safety, or other challenges?

The Health and Environmental Sciences Institute (HESI) seeks your suggestions for priority emerging scientific issues (human or environmental health) that should be addressed through a focused, multi-sector, collaborative program. Proposals will be reviewed in early 2025 and one or more may be selected to form a new scientific program within HESI.

This is NOT a grant program and no direct financial awards to external parties will be made. However, selected programs may receive funding in the form of HESI support for scientific program design, coordination, and staffing. We are seeking topics that focus on the applied human and/or environmental health sciences and that require scientific perspectives and expertise from academia, government, industry, NGOs, clinicians, and/or other research sectors.

Looking for somewhere to start? Learn more about HESI’s existing scientific activities on our committees page and in the 2023 Annual Report. These resources may help guide you when considering your idea, however, HESI welcomes all new proposals whether they are captured in these lists or not.

The deadline to submit proposals for consideration is 17 January 2025.

Click here to Access the 2025 Proposal Form

For questions contact Jennifer Pierson.

HESI’s Committee on Transforming the Evaluation of Agrochemicals (TEA) invites you to participate in the TEA Global Challenge, a groundbreaking initiative focused on advancing ecological and human safety assessments of plant protection products using non-animal methods. This year’s challenge focuses on the safe use of a hypothetical grape fungicide (VineGuard).

Not familiar with agrochemicals? No problem! Anyone can participate!

Your mission is to propose creative solutions to evaluate the safety of VineGuard.

We offer great flexibility in how you can participate:

• You are free to choose the scope of the problem you want to solve.
• You can propose conceptual solutions (simply explain how you would proceed) or more specific solutions based on hypothetical datasets of your choice.
• You only need to explain your approach, using the provided reporting template.

Exciting Rewards:

• $2,000 USD in travel funds to attend a relevant scientific conference.
• Support from the HESI TEA committee to publish your work.

For detailed guidelines, visit TEA Global Challenge website.

Watch our recent webinar outlining the Challenge!

DONOR RELATIONS and OPERATIONS MANAGER

Want to work for a nonprofit organization that creates science-based solutions for a safer, more sustainable world? Join HESI as a Donor Relations and Operations Manager, where you’ll manage key donor relationships, support institutional operations, accounting, and budgets as part of HESI’s effort to address global health and environmental challenges.

This position works in Washington, DC, and reports to the HESI Executive Director.

KEY RESPONSIBILITIES

Donor Management

• Manages key facets of donor stewardship including processing annual donor invoices, maintaining lists of key contacts in donor organizations, fulfilling payment-related donor information requests, and working with HESI leadership and management staff to address other donor-related reporting as assigned.
• Leads annual member outreach activities to donors through dissemination of customized HESI Sponsorship reports as prepared by the HESI Scientific Staff.
• Maintains member information in the Constant Contact database.
• Reports to Executive Director/Deputy Director on trends in donor composition.
• Assists the Associate Director for Program Development & Resourcing in tracking of grants and grant-related contracts.

Operational Management

• Works directly with HESI’s finance department and legal department to support HESI operations and the annual organizational financial audits and other compliance requirements.
• Supports the Executive Director in disseminating communications and requests to the HESI Board of Trustees and broad HESI membership. This includes engaging directly with members of HESI’s global Board of Trustees to communicate logistical and administrative needs, scheduling and providing logistical support for Board-related events and activities.
• Identifies opportunities to enhance and streamline internal systems to support the work of the organization.
• Manages organization-wide vendor contracts, payment, and financial transactions.
• In partnership with senior HESI staff, monitors organizational budget relative to Board expenditures and expenses for Bi-Annual Scientific Conference.
• Leads logistical support for events, meetings and conferences for HESI and its programs on an as needed basis. This may include coordinating banquet event orders (BEOs), and providing onsite logistical support, and assisting with booking guest travel for events.
• Adhere to strict deadlines for completion of all assigned work.
• Completes special projects and ad hoc tasks as needed to support the organization.
• Exercise a high degree of judgment and discretion while collaborating with leaders and staff throughout the organization.

Knowledge, Skills, Abilities and Experience

• Familiarity with nonprofit member and donor management a plus.
• Bachelor’s degree or equivalent experience required, with a minimum of 3+ years of work experience involving increasing responsibilities in a related field or discipline such as project management, donor relations, grant management, membership management, nonprofit administration, or similar.
• Proficiency with the Windows environment and MS Office suite, along with experience using databases like Constant Contact and PN3 (AR/AP) preferred.
• Ability to quickly learn and adapt to new software and technologies as needed.
• Proven track record of strategic and creative approaches to tasks.
• Demonstrated ability to lead and manage multiple, concurrent projects with strong organizational skills, setting priorities, and meeting tight deadlines in a dynamic environment.
• Flexible and adaptable to shifting priorities and new tasks, with a proactive approach to managing change.
• Self-motivated and able to work well with and through others, having a strong commitment to customer service.
• Strong attention to detail and superior verbal, writing, and proofreading skills.
• Ability to travel domestically or internationally.

Work Environment and Additional Tasks

• This role involves work performed in an office or similar environment and may involve extended periods of sitting, working at a computer, and supporting meeting logistics.
• Occasional physical tasks may include lifting and moving items up to 20+ pounds, such as boxes or meeting materials, and setting up or breaking down event logistics.
• Mobility in confined or restricted spaces may be required for brief periods, particularly when supporting meetings or event logistics, which may involve occasional movement or physical tasks.

ABOUT HESI

At HESI, it is our mission to collaboratively identify and help to resolve global health and environmental challenges through the engagement of scientists from academia, government, industry, clinical practice, research institutes and NGOs. We achieve that in a variety of ways:

• Create a collaborative environment where scientists from academia, government, industry, and NGOs come together to find solutions that improve health and environmental safety.
• Encourage the development of meaningful studies that ask the right questions, structure the right framework, and develop solutions that inform decision-making by both private- and public-sector scientists.
• Create a knowledge base that can be easily transferred from the laboratory or journal page to real life.

Individuals interested in applying for this position should send their RESUME with COVER LETTER to Career@hesiglobal.org.

Principals only, please. Unsolicited resumes from third-party agencies will not be considered. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Learn more about us at www.hesiglobal.org.

SCIENTIFIC PROGRAM MANAGER

Looking for an exciting career in human or environmental toxicology, drug safety, biomedical innovation, regulatory science, epidemiology, exposure-science, and risk assessment — outside of the lab?

Want a great place to grow your career via collaboration with thought-leaders from government, industry, academia, clinic, and NGOs?

Seeking an opportunity to apply your skills in leadership and program management while applying science to real world challenges?

The Health and Environmental Sciences Institute (HESI), a global nonprofit scientific organization, seeks a Scientific Program Manager to help lead collaborative scientific programs in the biomedical and environmental health fields. Successful candidates will have a passion for fostering creative and rigorous scientific collaborations that pool expertise, resources, and technical input from a diverse base of stakeholders. HESI Scientific Managers are responsible for developing, managing, and providing scientific input to large international scientific teams that generate science to protect public health and the environment. HESI offers the opportunity to work with internationally recognized scientists from government, academia, NGOs, clinic, and industry. This responsible position requires leadership skills and the ability to work as part of a team to help realize HESI’s mission of achieving science for a safer, more sustainable world.

This position works in Washington, DC, and reports to the HESI Executive Director.

KEY RESPONSIBILITIES

Provides scientific, strategic, management, and administrative support to collaborative scientific committees involving academic, government, nonprofit, and private sector scientists;

Works with committee members to design and execute novel scientific research programs, publications, workshops, and trainings;

Prepares and monitors committee budgets, assists with communications (technical and non-technical), supports membership development, facilitates workshops and meetings, and contributes to overall HESI strategy and outreach.

QUALIFICATIONS

• A Master’s or Ph.D. in a scientific field such as toxicology, pharmacology, genetics, immunology, epidemiology, genetics, molecular biology, cell biology, pathology, chemistry, environmental health, or related life sciences and a minimum of 3 years of experience in project management, drug or chemical safety evaluation, scientific consulting, and/or regulatory affairs.
• Strong facilitation skills and the ability to work with groups meeting virtually or in person.
• Advanced written and verbal communication skills, outstanding management and organizational ability.
• At least 5 years of experience in project or program coordination.
• Leadership experience and presentation skills.
• Technical/scientific writing.

EXPERIENCE

Expertise in any/all of the following areas preferred:

• Regulatory Science
• Exposure Science
• Drug Safety Assessment
• Chemical Safety Assessment
• Computational Toxicology
• ADME

ABOUT HESI

At HESI, it is our mission to collaboratively identify and help to resolve global health and environmental challenges through the engagement of scientists from academia, government, industry, clinical practice, research institutes and NGOs. We achieve that in a variety of ways:

• Create a collaborative environment where scientists from academia, government, industry, and NGOs come together to find solutions that improve health and environmental safety.
• Encourage the development of meaningful studies that ask the right questions, structure the right framework, and develop solutions that inform decision-making by both private- and public-sector scientists.
• Create a knowledge base that can be easily transferred from the laboratory or journal page to real life.

Individuals interested in applying for this position should send their RESUME with COVER LETTER to Career@hesiglobal.org.

Principals only, please. Unsolicited resumes from third-party agencies will not be considered. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Learn more about us at www.hesiglobal.org.

As the days grow shorter here in Ottawa, where I live, I’m reminded that this time of year can be challenging for many of us in the northern hemisphere. With fewer daylight hours, we feel the impact of longer nights and cooler temperatures. However, it’s also a time when we start thinking about the agendas for upcoming HESI meetings—a chance to reflect on our accomplishments and plan for the future. This process shines a light on how HESI continues to drive progress in health and environmental sciences.

As Chair of the Board of Trustees, I’m honored to have a unique perspective on the inspiring work that goes on behind the scenes here. From supporting our Executive leadership team to collaborating with our scientific managers, I’m privileged to contribute to HESI efforts and learn from the brilliant people who make up HESI. It’s especially rewarding to interact with our board of trustees—a remarkable group of experts from industry, government, and academia—each of whom brings a wealth of knowledge and vision to our mission.

Looking through this month’s newsletter, I’m struck by how HESI’s impact spans so many critical areas: from high-quality scientific publications to regulatory guidance, from advancing safety sciences to improving patient care. We’re supporting education globally, extending learning from public schools to professional training, and every initiative contributes to the larger mosaic of HESI’s influence on health and safety worldwide.

In Canada and the USA, fall is also a time to give thanks. So, I’d like to conclude by expressing my gratitude to everyone who makes the exceptional work at HESI possible. As the days grow shorter, this newsletter reminds us how HESI’s contributions shine ever brighter with each passing season.

Best wishes,

Carole Yauk, PhD, CAHS
Chair of the HESI Board of Trustees